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Edited By : Renée Deveney
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Oxbryta Side Effects & Risks Linked to Lawsuits

People began filing Oxbryta lawsuits after research exposed the drug was associated with an increased risk of death and worsening side effects, including vaso-occlusive crises.

Oxbryta (voxelotor) was used to treat sickle cell disease. Pfizer, its manufacturer, issued a worldwide Oxbryta recall and took it off the market in September 2024 due to severe health risks, including 16 deaths in a pair of clinical trials.

“Pfizer's decision is based on the totality of clinical data that now indicates the overall benefit of Oxbryta no longer outweighs the risk in the approved sickle cell patient population.”

Lawsuits argue that while Oxbryta was meant to help deliver oxygen to the body by stabilizing hemoglobin, it had the opposite effect. Instead, it increased the chances of death and caused painful complications called vaso-occlusive crises.

Vaso-occlusive crises happen when sickled blood cells block small blood vessels, causing severe pain and health issues like strokes and acute chest syndrome. Two clinical trials reported alarming results, including a disproportionate number of deaths and vaso-occlusive crises among participants.

Why Are People Filing Oxbryta Lawsuits?

People are filing Oxbryta lawsuits against the drug’s makers, claiming that Pfizer and Global Blood Therapeutics did not take proper care when developing and selling it. The lawsuits allege that these companies didn’t warn patients about the drug’s possible dangers, promoted it misleadingly and sold a product with serious flaws.

In addition, the U.S. Food and Drug Administration has also reported over 21,000 reports of adverse events from people who took the medication while it was on the market.

Oxbryta Adverse Events Reported to FDA 2020 - 2024
  • Total adverse events: 21,554
  • Most frequent event: Sickle cell crisis (includes vaso-occlusive crises), 10,850
  • Total deaths reported: 369

The FDA approved Oxbryta through its accelerated approval pathway in 2019 for sickle cell patients 12 and older. It used the same process in 2021 for patients four to 11.

Accelerated approval requires drug makers to conduct postmarketing clinical trials. These mandatory studies revealed significant risks, leading to Oxbryta’s market withdrawal.

The people filing lawsuits seek compensation for medical expenses, lost income and other financial hardships. They also want additional penalties to hold the companies accountable for their actions and cover their legal costs.

These legal actions aim to address the problems caused by the risks associated with Oxbryta, which led to its removal from the market.

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Oxbryta Case Study: Oxbryta Blamed for a Stroke

Tirrell Allen
In 2024, Tirrell Allen, a 43-year-old from Illinois with sickle cell disease, filed a lawsuit against Pfizer and Global Blood Therapeutics over injuries he claims were caused by Oxbryta. Marketed as a daily treatment to improve patients’ lives, Allen alleges the drug caused him serious harm.

Serious Injuries
In August 2024, Allen started taking Oxbryta. He began experiencing more frequent and painful vaso-occlusive crises. In September 2024, he had a severe crisis that resulted in a stroke and hospitalization.

Allen’s Lawsuit
Allen’s lawsuit against Pfizer claims the company withheld risks of Oxbryta, including higher chances of health crises and death. Allen seeks compensation for injuries and losses, holding the manufacturer accountable.

Oxbryta Lawsuit Updates & Legal News

As of 2025, Oxbryta lawsuits are in the early stages. There have been no trials, verdicts or settlements. Cases have been filed in state and federal courts involving people from multiple states.

This opens the door for an eventual multidistrict litigation if plaintiffs file multiple Oxbryta lawsuits. Multidistrict litigations combine similar lawsuits into a single court to make the legal process more efficient.

Oxbryta Lawsuit Timeline
  • February 2025:
    A total of six Oxbryta lawsuits have been filed. The litigation is in its early stages. Discovery, which is the process of gathering evidence, has not started.
  • November 2024:
    Tirrell Allen files one of the earliest Oxbryta lawsuits in a California federal court.
  • September 2024:
    Pfizer voluntarily withdraws all doses of Oxbryta from the global market, declaring “the overall benefit of Oxbryta no longer outweighs the risk in the approved sickle cell patient population.”
  • July 2024:
    The European Medicines Agency (the European Union’s counterpart to the U.S. Food & Drug Administration) begins reviewing two clinical trials paused for safety concerns two months earlier.
  • May 2024:
    Two Oxbryta clinical trials are stopped after a total of 16 deaths and increased numbers of serious side effects.
  • December 2021:
    The U.S. Food & Drug Administration grants accelerated Oxbryta approval for sickle cell patients four years and older.
  • November 2019:
    Oxbryta receives U.S. Food & Drug Administration approval for treating sickle cell disease in patients 12 and older. The drug was cleared through the accelerated approval process.

Who Qualifies for an Oxbryta Lawsuit?

You may qualify for an Oxbryta lawsuit if you have sickle cell disease, were prescribed Oxbryta for daily use and experienced serious health issues or worsening of existing conditions after starting the medication.

Common Injuries Listed in Oxbryta Lawsuits
  • Acute chest syndrome
  • Arthritis
  • Blood clots
  • Bone necrosis
  • Hypertension
  • Kidney failure
  • Leg ulcers
  • Liver failure
  • Pneumonia and other serious infections
  • Sleep apnea and related sleep conditions
  • Stroke
  • Vision loss

To file a lawsuit, you must provide evidence of your diagnosis, Oxbryta prescription and a clear link between the medication and your health problems. Families who lost a loved one due to these complications may also qualify.

Filing an Oxbryta Lawsuit

Filing an Oxbryta lawsuit involves gathering key evidence, consulting an experienced attorney and meeting critical deadlines. Understanding the process can help you take the necessary steps to seek compensation for your injuries or losses.

Gather evidence
Before you talk to an attorney, gather your medical records, including your sickle cell disease diagnosis, prescriptions and documents related to your side effects after you started taking Oxbryta. These will help your attorney determine if you have a case and what compensation you may be entitled to.
Contact an experienced attorney
Drug lawsuits are complicated. You will want to consult a lawyer specializing in drug and medical device lawsuits. Consumer Notice partners with leading national law firms that focus on these cases. We can help you connect with the best lawyer for your case.
File before the deadline
You have a limited time to file a lawsuit. The statute of limitations varies from state to state, and it can be as little as one year from when Oxbryta injured you. It’s essential to speak with an attorney right away.

Lawyers who handle personal injury lawsuits, like the Oxbryta lawsuits, typically work on a contingency basis. This means they don’t take payments from you unless they win your case. Consulting with them is usually free, but you should ask any attorney about fees before committing to them.

Editor Lindsay Donaldson contributed to this article.

Please seek the advice of a qualified professional before making decisions about your health or finances.
Last Modified: March 4, 2025

13 Cited Research Articles

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  1. Nolo. (2025, January 3). Civil Statutes of Limitations. Retrieved from https://www.nolo.com/legal-encyclopedia/statute-of-limitations-state-laws-chart-29941.html
  2. U.S. Food & Drug Administration. (2024, December 31). FDA Adverse Event Reporting System (FAERS) Public Dashboard. Retrieved from https://www.fda.gov/drugs/fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-public-dashboard
  3. U.S. District Court for the Northern District of California. (2024, November 7). Allen v. Global Blood Therapeutics, Inc. Retrieved from http://www.pacer.gov
  4. Sickle Cell Disease Association of America. (2024, September 27). MARAC Statement: Pfizer’s Voxelotor (Oxbryta®) Withdrawal. Retrieved from https://www.sicklecelldisease.org/2024/09/28/marac-statement-oxbryta/
  5. European Medicines Agency. (2024, September 26). EMA Recommends Suspension of Sickle Cell Disease Medicine Oxbryta. Retrieved from https://www.ema.europa.eu/en/news/ema-recommends-suspension-sickle-cell-disease-medicine-oxbryta
  6. European Medicines Agency. (2024, September 26). EMA Starts Review of Sickle Cell Disease Medicine Oxbryta. Retrieved from https://www.ema.europa.eu/en/documents/referral/oxbryta-article-20-procedure-ema-starts-review-sickle-cell-disease-medicine-oxbryta_en.pdf
  7. Gallagher, A. (2024, September 26). Pfizer Withdraws Voxelotor From Approved Markets, Will Discontinue Trials. Retrieved from https://www.pharmacytimes.com/view/pfizer-withdraws-voxelotor-from-approved-markets-will-discontinue-trials
  8. U.S. Food and Drug Administration. (2024, September 26). FDA Is Alerting Patients and Health Care Professionals About the Voluntary Withdrawal of Oxbryta from the Market Due to Safety Concerns. Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerting-patients-and-health-care-professionals-about-voluntary-withdrawal-oxbryta-market-due
  9. Pfizer. (2024, September 25). Pfizer Voluntarily Withdraws All Lots of Sickle Cell Disease Treatment OXBRYTA® (voxelotor) From Worldwide Markets. Retrieved from https://www.pfizer.com/news/press-release/press-release-detail/pfizer-voluntarily-withdraws-all-lots-sickle-cell-disease
  10. Cleveland Clinic. (2024, August 29). Sickle Cell Crisis. Retrieved from https://my.clevelandclinic.org/health/diseases/sickle-cell-crisis
  11. European Medicines Agency. (2024, July 30). Notification to the CHMP/EMA Secretariat of a Referral Under Article 20 of Regulation (EC) 726/2004/. Retrieved from https://www.ema.europa.eu/en/documents/referral/oxbryta-article-20-procedure-notification_en.pdf
  12. Blair, H. A. (2020, February). Voxelotor: First Approval. Retrieved from https://pubmed.ncbi.nlm.nih.gov/32020554/
  13. Be The Spark. (n.d.). Symptoms and Complications. Retrieved from https://www.sparksicklecellchange.com/what-is-sickle-cell/symptoms-complications